Twenty-two priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Despite expansions of HIV prevention programs in Nigeria, only 14% of pregnant women were tested for HIV; while 9% of pregnant women living with HIV received WHO recommended antiretroviral (ARV) therapy; and only 11% of HIV-exposed infants received ARV prophylaxis for prevention of mother-to-child HIV transmission (PMTCT) resulting in an estimated 75,000 HIV-infected infants in 2010. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available PMTCT interventions. This clinic-based approach is challenging when only 35% of pregnant women deliver in a HF and only 2.9% of HF have an established PMTCT program. Finding new approaches to translate evidence-based PMTCT programs to community-based setting is necessary if we are to realize the PEPFAR goal of 80% HIV screening rate among pregnant women by 2015. Nigeria is ranked #1 among 53 nations surveyed by Pew Center in church attendance. The availability of at least one faith-based institution in each community presents a unique opportunity to evaluate the effect of a congregation-based approach to HIV testing among pregnant women, and their male partners as well as completion of PMTCT interventions among HIV-infected pregnant women. Thus we propose a cluster randomized trial to evaluate the comparative effectiveness of a congregation-based Healthy Beginning Initiative delivered by lay health advisors (Intervention Group; IG), versus a clinic-based approach (Control Group; CG) on the HIV testing rate and PMTCT completion among 2700 pregnant women. Forty churches in South-east Nigeria will be randomly assigned (1:1) to either the IG or the CG. The Healthy Beginning Initiative combines a family educational game show and an integrated on-site laboratory testing delivered in the context of a baby shower. Monthly prayer sessions for pregnant women will be used for recruitment and baby receptions following infant baptisms will be used for follow up after delivery. The primary outcome is the difference in HIV testing rate between both groups. The secondary outcomes are the difference in HIV testing rate among male partners and PMTCT completion rate among HIV-infected pregnant women for both groups. Pregnant women will complete an investigator-administered questionnaire to collect information on HIV testing and PMTCT completion. Self-reported data will be confirmed with on-site testing data and HF. This proposal is a collaboration among Partners for Prevention, Education, Training, Treatment and Research (PeTR-Global Solutions)/AIDSRelief (our PEPFAR-funded partner in Nigeria who will be responsible for training, HIV testing, linkage to treatment and local oversight of the project); New York University School of Medicine (program evaluation and shares oversight with PI), Board of Regents, NSHE, obo University of Nevada, Reno (provide overall oversight, data management and evaluation of program effectiveness). PUBLIC HEALTH RELEVANCE: Interventions targeted at increasing the rate of HIV testing among pregnant women and their male partners are urgently needed to address the epidemic of mother-to-child HIV transmission and its associated morbidity, mortality and societal costs in Sub-Saharan Africa. Using a cluster randomized trial design among 2700 pregnant women followed in 40 churches in Nigeria, the goal of the proposed study is to evaluate the comparative effectiveness of a congregation-based versus clinic-based approach on HIV testing and PMTCT completion rates. Findings from this study will provide policy makers and funding agencies needed information on effective, sustainable community-based approaches to increase HIV testing among pregnant women and their male partners.